Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

Summary

This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.

Conditions

• Ganglioneuroblastoma
• Localized Resectable Neuroblastoma
• Localized Unresectable Neuroblastoma
• Regional Neuroblastoma
• Stage 4 Neuroblastoma
• Stage 4S Neuroblastoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo radiotherapy

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous in vitro-treated peripheral blood stem cell transplantation

DRUG

Busulfan

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide Phosphate

Given IV

RADIATION

External Beam Radiation Therapy

Undergo radiotherapy

PROCEDURE

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

Undergo autologous in vitro-treated peripheral blood stem cell transplantation

RADIATION

Intensity-Modulated Radiation Therapy

Undergo radiotherapy

RADIATION

Iobenguane I-131

Given IV

DRUG

Isotretinoin

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

OTHER

Pharmacological Study

Correlative studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Brian D Weiss · Children's Oncology Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-21

Primary Completion

2016-09-28

Completion

2025-12-31

Countries

• United States

Study Locations